Editor's Note The Food and Drug Administration (FDA) has dropped its recall of approximately 2,800 Custom Ultrasonics’ System 83 Plus automated endoscope reprocessors. This action comes despite the FDA's finding last year that the recall was “necessary to protect public health,” the May 6 Kaiser Health News reports. The FDA…

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Editor's Note A new congressional investigation shows that the number of infections from contaminated duodenoscopes is much higher than previously estimated, the April 15 Los Angeles Times reports. The Food and Drug Administration (FDA) told investigators that from 300 to 350 patients at 41 facilities in the US and abroad…

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Editor's Note The Food and Drug Administration (FDA) on March 15 announced that Olympus (Center Valley, Pennsylvania) has issued updated, validated manual reprocessing instructions for the TJF-160F and TJF-160 VF duodenoscope models to replace those provided in the original device labeling. The FDA reviewed the updated reprocessing instructions and the…

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Editor's Note The Food and Drug Administration (FDA) on February 19 announced that it had reviewed updated reprocessing instructions and validation data issued by Pentax Medical (Montvale, New Jersey) for its ED-3490 Video Duodenoscope. The FDA recommends that facilities train staff on the updated instructions and implement them as soon…

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Sterilization packaging is considered a medical device and thus it must undergo validation testing before being used in healthcare facilities. To ensure proper packaging that will maintain the integrity of sterilization, consult the packaging manufacturers’ instructions for use (IFU) and follow the sterilization standards and guidelines from the Association for…

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Editor's Note The Food and Drug Administration (FDA) on February 1 posted updated information on which manufacturers of automated endoscope reprocessors (AERs) for duodenoscopes have completed validation testing with adequate results. There are five companies in the US that manufacture AERs labeled to reprocess duodenoscopes. Companies that have completed their…

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Editor's Note Nearly 300 patients who had colonoscopies at Baystate Noble Hospital in Westfield, Massachusetts, may have been exposed to HIV and hepatitis because of a lack of adequate disinfection measures used to clean endoscopes, the January 23 Tech Times reports. The hospital started using new equipment that required a…

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Editor's Note The Food and Drug Administration (FDA) on January 21 issued final guidance for “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." The document updates and clarifies information regarding sterilization processes and details about pyrogenicity the FDA recommends that sponsors include…

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Using best practices to sterilize surgical instruments can help lower infection rates and, in some cases, prevent death. Over the past few years, staff at Banner Boswell Medical Center in Sun City, Arizona, have worked to reduce immediate use steam sterilization (IUSS) rates. Thanks to improved communication and workflow between…

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Editor's Note Sterilized wrapped instrument trays demonstrated significantly greater protection than sterilized rigid containers against the ingress of airborne bacteria in this study. Of 111 rigid containers tested, 97 failed to maintain barrier performance, allowing bacterial ingress, while 0 of 161 wrapped trays had detectable contamination. Contamination rates of rigid…

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